Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries (AlterG)

• ClinicalTrials.gov Identifier: NCT03562364
• Recruitment Status: Recruiting
• First Posted: June 19, 2018
• Last Update Posted: August 12, 2020
• Sponsor: Major Extremity Trauma Research Consortium
• Information provided by (Responsible Party): Major Extremity Trauma Research Consortium

Study Description

Brief Summary:

The overall objective of this study is to compare outcomes following early advanced weight bearing (EAWB) using the AlterG antigravity treadmill versus standard of care physical therapy for adult patients with lower extremity periarticular injuries.

Condition or disease	Intervention/treatment	Phase
Distal Femur Fracture; Tibial Plateau Fracture; Distal Tibia Fracture; Pilon Fracture	Other: AlterG anti-gravity treadmill	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries: An RCT Using the Anti-Gravity Treadmill (AlterG)
• Actual Study Start Date: February 25, 2019
• Estimated Primary Completion Date: February 2021
• Estimated Study Completion Date: February 2021

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Standard of Care; The standard of care group will remain non-weight bearing for 10-12 weeks following definitive fixation and receive physical therapy in accordance with standard practice at the treating center.
Experimental: Early Advanced Weight Bearing (EAWB); The Early Advanced Weight Bearing (EAWB) group will receive early weight-bearing treatment using the antigravity AlterG treadmill. These sessions will begin 14-28 days following definitive fixation and last for a total of 10 weeks	Other: AlterG anti-gravity treadmill; The AlterG treadmill is an FDA approved device that allows patients to perform early partial weight bearing exercises in a tightly controlled and safe environment

Outcome Measures

Primary Outcome Measures :

1. Patient Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: up to 12 months ]
   PROMIS Computer Adaptive Test (CAT) item banks for physical function, depression, anxiety, pain, fatigue, sleep, and social activity participation will be administered on a tablet. Scores for each item bank are calculated electronically.
2. The Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: up to 12 months ]
   The KOOS is a 42 item assessment that evaluates joint function by asking patients to rate their symptoms and concerns in 5 domains: pain, other symptoms, function in daily living (ADL), function in sport and recreation, and foot and ankle quality of life on a scale of 0-4.
3. Ankle Osteoarthritis Score (AOS) [ Time Frame: up to 12 months ]
   The AOS is an assessment that evaluates joint function by asking patients to rate their pain and disability while performing 18 different activities of daily living using a visual analogue scale
4. Work Productivity and Activity Impairment (WPAI) [ Time Frame: up to 12 months ]
   Return to Usual Major Activities or Duty will be assessed by asking participants what they were doing most of the time during the previous two weeks (working/active duty, laid off/looking for work, going to school, taking care of a home etc.). If participants are working, the WPAI questionnaire will be administered. The WPAI measures work time missed and work and activity impairment because of a specified health problem during the past 7 days
5. Range of Motion (ROM) [ Time Frame: up to 12 months ]
   Knee and ankle ROM measured with a goniometer
6. Knee Strength [ Time Frame: up to 12 months ]
   Knee strength will be assessed with dynamometer
7. Ankle Strength [ Time Frame: up to 12 months ]
   Ankle strength will be assessed by ability to perform heel raises
8. The Four Square Step Test (FSST) [ Time Frame: up to 12 months ]
   This test is a dynamic test of balance and agility. It requires participants to rapidly change direction while stepping forward, backward, and sideways, over a low obstacle
9. The Illinois Agility Test [ Time Frame: up to 12 months ]
   This is a commonly used test to measure agility by requiring the patient to turn in different directions and at different angles. The test requires the patient to navigate through a series of cones placed 3.3 meters apart as quickly as possible. It is simple test to administer and requires little equipment. The test is timed using a stopwatch and requires 10 meters of length, 5 meters of width, and 8 cones (or markers of some kind)
10. The 5x Sit-to-Stand Test (STS5) [ Time Frame: up to 12 months ]
    This is is a commonly performed to assess lower extremity strength, endurance, and mobility. This test measures time to complete 5 full stands from a sitting position. Participants sit in a straight back chair 44.5 cm high and 38 cm deep and are asked to fold their arms across their chests and to stand up from a sitting position once. If they successfully rise, they are asked to stand up and sit down 5 times as quickly as possible. Time to stand is measured using a stopwatch. Raw scores can be transformed into a rate per minute to accurately assess change in those who were unable to perform the test at any point
11. Timed Stair Ascent [ Time Frame: up to 12 months ]
    The timed stair ascent is an objective measure of mobility and power. Patients are asked to climb a flight of 12 stairs at their maximal rate, with or without holding onto the railing. The rater uses a stopwatch to determine the time required to reach the top of the steps
12. Self-selected walking velocity over level terrain (SSWV-L) [ Time Frame: up to 12 months ]
    The SSWV-L is a commonly used measure of speed and general physical capacity. Subjects will be asked to walk 30 feet on a level surface, at a comfortable pace, with or without an assistive device. Use of assistive devices will be recorded, as described above. The time it takes for subjects to complete the task is measured with a stop watch and recorded as feet per second (ft/sec)
13. 10 Meter Shuttle Run (40D) [ Time Frame: up to 12 months ]
    The 10 meter shuttle run assesses speed. Research staff will measure out a continuous 10 meter stretch that is free of obstacles. This test requires the person to run or walk back and forth between two parallel lines as fast as possible. Patients will start in a standing position and run or walk at their self-selected maximal rate 10 meters and back, for a total of 40 meters. The rater uses a stopwatch to keep time
14. Single Leg Stance [ Time Frame: up to 12 months ]
    The single leg stance is a measure of postural stability. Participants will be asked to stand with arms crossed and pick one foot off the ground bending the knee to 90 degrees. The rater uses a stopwatch to time how long participants hold this stance, up to 60 seconds. This test is done on both legs
15. Satisfaction with Physical Therapy and Recovery [ Time Frame: 12 month visit ]

    Satisfaction will be assessed during the final therapy visit using 3 questions designed specifically for this study:

    1. How would you rate your satisfaction with the physical therapy you received for your injury? Please choose a number from 0 to 10 with 0 being not at all satisfied and 10 being extremely satisfied.
    2. How satisfied are you with the progress you have made in recovering from your injury. Again, please use a number from 0 to 10 with 0 being not at all satisfied and 10 being extremely satisfied.
    3. Would you recommend this physical therapy program to other people with injuries like yours? Would you say definitely yes, probably yes, probably no or definitely no?
16. Fracture Healing [ Time Frame: up to 12 months ]
    Fracture healing will be assessed by clinical and radiographic examinations.These assessments will occur (and be recorded) at any standard of care visits that include radiographic examinations even if these visits are not part of the study schedule. Healing will be determined as "healed" or "not healed" based on orthogonal radiographs examined by the treating physician
17. Integrity of Fracture Fixation and Alignment [ Time Frame: up to 12 months ]
    Evidence of fracture fixation loss (e.g. changes in alignment, loosening of screws, fracture of implants, etc.) will be assessed at each study visit. These assessments will also occur prospectively at any other standard of care visits that include radiographic examinations. Ankle fracture alignment will be assessed by measuring the medial joint space on a mortise view radiograph (with the ankle in neutral dorsiflexion) and compared to the initial postoperative radiograph. Knee fracture alignment will be assessed by measuring the anatomic alignment on an anterior-posterior radiograph and on a lateral radiograph compared to the initial postoperative radiograph
18. Complications [ Time Frame: up to 12 months ]
    The presence of all limb related complications will be recorded prospectively at each follow up visit, and categorized accordingly

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Ages 18-55
• Closed or Open (Gustilo Type I, II or IIIA) fractures: Distal femur (AO/OTA 33B, 33C), tibial plateau (AO/OTA 41B, 41C), or Distal tibia/pilon (AO/OTA 43B, 43C)
• Definitively treated with a plate
• Ambulatory prior to injury
• Able to participate in rehab starting 28 days after definitive fixation
• Meets AlterG requirements (4'8- 6'4; 85-400lbs)

Exclusion Criteria:

• Medical or psychological disease that would preclude safe functional testing (e.g., severe traumatic brain injury, stroke, heart disease, etc.)
• Prior joint trauma or disease of the operative extremity that resulted in pain, stiffness, or other limitation to mobility
• Injury to the contra-lateral limb, upper extremities or axial skeleton that would influence single limb weight-bearing or use of an assistive device
• Pregnancy
• Unable to speak English
• Severe problems with maintaining follow-up (e.g. patients who are prisoners, homeless at the time of injury, who are intellectually challenged without adequate family support, or have documented psychiatric disorders).
• Unable to provide informed consent.

Contacts and Locations

Contacts

Contact: Lisa Reider, PhD; 4105023962; lsemani1@jhu.edu

Contact: Craig Remenapp, MS; 4106143576; cremena1@jhu.edu

Locations

United States, California

Naval Medical Center San Diego; Recruiting

San Diego, California, United States, 92134

Contact: Sally Morgan, BA Sally.a.morgan6.ctr@mail.mil

Principal Investigator: Kevin Kuhn, MD

University of California at San Francisco; Recruiting

San Francisco, California, United States, 94110

Contact: Eleni Berhaneselase Eleni.Berhaneselase@ucsf.edu

Principal Investigator: Saam Morshed, MD

United States, Kentucky

University of Kentucky; Recruiting

Lexington, Kentucky, United States, 40506

Contact: Paul Stringer, BS paul.stringer@uky.edu

Principal Investigator: Paul Matuszewski, MD

United States, Maryland

Walter Reed National Military Medical Center; Recruiting

Bethesda, Maryland, United States, 20889

Contact: Whitley Lucio whitley.b.lucio.ctr@mail.mil

Principal Investigator: Benjamin Potter, MD

United States, Minnesota

Hennepin County Medical Center; Recruiting

Minneapolis, Minnesota, United States, 55415

Contact: JR Westberg Jerald.Westberg@hcmed.org

Principal Investigator: Andrew Schmidt, MD

United States, Texas

University of Texas Health Science Center - Houston; Recruiting

Houston, Texas, United States, 77030

Contact: Sterling Boutte Sterling.Boutte@uth.tmc.edu

Principal Investigator: Joshua Gary, MD

San Antonio Military Medical Center (SAMMC); Recruiting

San Antonio, Texas, United States, 78234

Contact: Joseph Kimmel joseph.e.kimmel2.ctr@mail.mil

Principal Investigator: Dan Stinner, MD

United States, Virginia

University of Virginia; Recruiting

Charlottesville, Virginia, United States, 22908

Contact: Ashley Byrne aeb6q@hscmail.mcc.virginia.edu

Principal Investigator: David Weiss, MD

Inova Fairfax Hospital; Recruiting

Falls Church, Virginia, United States, 22042

Contact: Lolita Ramsey, PhD lolita.ramsey@inova.org

Principal Investigator: Robert Hymes, MD

Naval Medical Center Portsmouth; Not yet recruiting

Portsmouth, Virginia, United States, 23708

Contact: Lorie Gower lorie.m.gower.ctr@mail.mil

Principal Investigator: Christopher Smith, MD

Sponsors and Collaborators

Major Extremity Trauma Research Consortium

Investigators

• Principal Investigator: Daniel Stinner, MD; Vanderbilt University Medical Center

More Information

• Responsible Party: Major Extremity Trauma Research Consortium
• ClinicalTrials.gov Identifier: NCT03562364
• Other Study ID Numbers: W81XWH-16-2-0060 AlterG
• First Posted: June 19, 2018
• Last Update Posted: August 12, 2020
• Last Verified: August 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Major Extremity Trauma Research Consortium:

anti-gravity

Additional relevant MeSH terms:

Fractures, Bone; Femoral Fractures; Tibial Fractures; Wounds and Injuries; Leg Injuries